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Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00600301
First received: June 30, 2006
Last updated: January 23, 2008
Last verified: January 2008
History of Changes
  Purpose

Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.


Condition Intervention Phase
Diffuse Diabetic Macular Edema
 Drug: Triamcinolone Acetonide and Bevacizumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Asociación para Evitar la Ceguera en México:

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Diffuse diabetic macular edema
  • Non proliferative diabetic retinopathy
  • No VPP previa
  • No previous treament with laser, Triamcinolone acetonide, and Bevacizumab

Exclusion Criteria:

  • Proliferative diabetic retinopathy
  • Previous pars plana vitrectomy
  • Previous treatment with diabetic macular edema
  • Focal macular edema
  • Macular Ischemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600301

Contacts
Contact: Maximiliano Gordon, MD 10841400 ext 1171, 1172 retinamex@yahoo.com

Locations
Mexico
Asociacion Para Evitar la Ceguera en Mexico Recruiting
Mexico D.F., D.f., Mexico, 04030
Contact: Maximiliano Gordon, MD     10841400 ext 1171, 1172     retinamex@yahoo.com    
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Maximiliano Gordon, MD APEC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00600301     History of Changes
Other Study ID Numbers: APEC-OO13
Study First Received: June 30, 2006
Last Updated: January 23, 2008
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Asociación para Evitar la Ceguera en México:
Macula
Edema

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013